Electronic Caries Detector
K-Number: K170822 · 2017-09-11
ApplicantOrtek Therapeutics, Inc.
Decision Date2017-09-11
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Electronic Caries Detector is a medical device manufactured by Ortek Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-09-11 under approval number K170822. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Electronic Caries Detector?
Electronic Caries Detector is a medical device that received FDA 510(k) clearance on 2017-09-11. It is manufactured by Ortek Therapeutics, Inc.. The 510(k) number is K170822.
When was Electronic Caries Detector approved by the FDA?
Electronic Caries Detector received FDA 510(k) clearance on 2017-09-11, under approval number K170822.
What company makes Electronic Caries Detector?
Electronic Caries Detector is manufactured by Ortek Therapeutics, Inc..
What is the FDA product code for Electronic Caries Detector?
The FDA product code for Electronic Caries Detector is NBL.
Related Devices (Code: NBL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.